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Hope for SCI patients in upper body function recovery

‘Functional recovery once deemed impossible may now be in reach’ – reaction to ONWARD study

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A pioneering study into the efficacy of spinal cord stimulation technology has delivered “statistically significant and clinically meaningful improvement” in upper body strength and function among people living with spinal cord injury (SCI). 

The Up-LIFT study has trialled the safety and effectiveness of ARC-EX therapy – created by ONWARD – in treating upper extremity functional deficits in people with chronic tetraplegia. It marks the first large-scale clinical study of non-invasive spinal cord stimulation. 

The international, multi-centre study – which involved two sites in the UK – enrolled 65 participants with an average time since injury of 5.9 years. Enrolment was completed ahead of schedule, despite the challenges presented by the pandemic. 

Revealing it had achieved its primary endpoint of improvement in upper extremity strength and function, ONWARD reiterated its ambition to launch ARC-EX commercially in the second half of 2023. 

“Our vision is to empower people with spinal cord injury to enjoy life in every way that matters to them. Today’s excellent results from the Up-LIFT study will help us transform that vision into reality”, said Dave Marver, ONWARD CEO. 

“Our team is working hard to prepare regulatory submissions and to get ready for launch in the US and Europe. 

“We are hopeful we can begin to positively impact the lives of people with spinal cord injury sometime during the second half of 2023.”

“The Up-LIFT study results represent a turning point in the field of spinal cord injury and paralysis science,” said Dr Marco Baptista, chief scientific officer of the Christopher & Dana Reeve Foundation. 

“Functional recovery once deemed impossible may now be in reach. The Reeve Foundation looks forward to this technology advancing and, we hope, becoming widely available to our community.” 

Medtech ONWARD continues to break new ground in its efforts to improve the lives of people living with paralysis, working to restore movement, independence and health.  

Its STIMO-BRIDGE study involving its implantable stimulation device ARC-IM delivered life-changing results for some participants, who live with paralysis. On the first day following implant, all participants were able to take steps independently on a treadmill with body weight support.

After five months of rehabilitation, participants were able to use their legs to stand, walk, swim, and/or cycle. They also regained control of their trunk muscles. 

Its ARC-EX technology is now delivering life-changing results to people in respect of their upper body control, with improvement in arm and hand function cited as being the highest priority among people with tetraplegia. 

Participants in the Up-LIFT study completed an average of 50 training sessions over a period of about four months. 

A series of comprehensive assessments were performed at baseline and monthly thereafter to detect changes in sensory and motor function of upper extremities that directly translate into improved functional performance in activities of daily living.

“Restoring hand and arm function after spinal cord injury is life-changing, freeing people with paralysis to feed and care for themselves and be more independent in everyday activities,” said Dr Chet Moritz, study co-principal investigator (co-PI) and Professor of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington. 

“We are grateful to the many therapists, clinicians, and people with SCI who participated in this landmark study. There was very low attrition over thousands of clinic visits, a testament to the collective enthusiasm for this compelling therapy and for everyone’s determination to find new treatment options for people with SCI,” added Dr Edelle Field-Fote, study co-PI, director of SCI Research at the Shepherd Center in Atlanta, GA, and Professor at Emory University School of Medicine in the Department of Rehabilitation Medicine. 

Detailed results will be made available after review by the FDA. The company plans to submit for regulatory approval in both the US and Europe within the next six months. 

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